Chronic Hepatitis BPhase 4NCT01264094
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
A Phase 4 study testing Clevudine in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Clevudine
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
- Patient is HBeAg positive or negative.
- Patient has ALT levels ≥ 80 IU/L
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon within the previous 3 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
- Conditions
- Chronic Hepatitis B
- Being tested
- Clevudine
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
clevudine 30 mg qd
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBV DNA below the assay limit of detection
Secondary outcomes (4)
The change of HBV DNA from the baseline.
Proportion of patients with HBeAg loss and/or seroconversion.
Biochemical improvement (e.g. ALT normalization).
Proportion of sAg loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2014
- Study completionJun 2015
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264094
- Sponsor's protocol ID
- CLV-408
- Status last verified
- Jul 2015
- First submitted
- 19 Dec 2010
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
- ClinicalTrials.gov ID
- NCT01264094
- Acronym / sponsor ID
- CLV-408
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
- Patient is HBeAg positive or negative.
- Patient has ALT levels ≥ 80 IU/L
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (8 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon within the previous 3 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient is pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clevudineclevudine 30 mg qd | Drug | – |
Primary outcome
Proportion of patients with HBV DNA below the assay limit of detection
4 secondary outcomes
The change of HBV DNA from the baseline.
Proportion of patients with HBeAg loss and/or seroconversion.
Biochemical improvement (e.g. ALT normalization).
Proportion of sAg loss
Results and safety
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Related trials for Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clevudine in people with Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HBV DNA below the assay limit of detection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015; AzTrials last refreshed its copy on 30 Oct 2026.